Medical diagnostic testing methods are critical screening tools for the early detection of pathological conditions. Early detection permits the identification of such conditions at a stage when successful treatment is more likely. Early treatment also frequently involves less damaging or less invasive treatment methods and decreases the impact on the patient. In addition to routine screening, diagnostic testing is also used in a variety of other applications, including biopsy analysis and monitoring the results of ongoing medical treatment.
One particularly useful tool in diagnostic testing is the Papanicolaou staining process. This process was first developed for the staining of gynecological specimens, and has led to a dramatic decrease in the fatality rate from cervical cancer. Papanicolaou staining is now used in diagnosing a variety of pathological conditions from many different tissues and organs.
However, Papanicolaou staining is subject to artifacts that can adversely affect the ability of a technologist or machine to successfully read a processed sample. These artifacts include spurious non-specific cytoplasmic staining, artifacts such as cytoplasmic cracking, cornflaking, smudged nuclear detail, hypochromatic staining and hyperchromatic staining. Such artifacts, at a minimum, reduce the fraction of the sample which can be evaluated, can produce false staining patterns that interfere with accurate diagnosis, and may render the sample unreadable. Difficulties in analyzing such samples leads to an increase in patient anxiety, rescreening costs, delays in diagnosis and, more importantly, potential misdiagnosis.
There is a need in the art for improved procedures for staining diagnostic specimens, and for compositions and articles of manufacture useful in such methods.